The United States’ top infectious disease official says experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early results from a key clinical trial showed it helped patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a US government trial showing that patients given remdesivir recovered 31 per cent faster than those given a placebo, were hailed by Dr Anthony Fauci as “highly significant”.
“This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing”.
“This will be the standard of care,” he said.
The US Food and Drug Administration said it has been in discussions with manufacturer Gilead Sciences about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.
“I want them to go as quickly as they can,” President Donald Trump said, when asked if he wanted the FDA to grant emergency use authorisation for remdesivir.
“We want everything to be safe, but we would like to see very quick approvals, especially with things that work.”
Interest in remdesivir has been high as there are no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases.
Doctors on the front lines of the COVID-19 battle have been eager for results from the study because it is a large trial in which patients were randomised to treatment with the drug or a placebo without participants or doctors knowing which group they were in – the gold standard for clinical trials.
Gilead earlier this month said the company was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir – enough for more than 140,000 patients depending on length of treatment. Regulatory approval of the drug would also clear the way for commercial sales.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said partial results from its 1063-patient trial show that hospitalised COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.
The study showed a trend toward better survival for remdesivir – 8 per cent of patients given the drug died compared with 11.6 per cent in the placebo group – but the difference was not statistically significant so may not be due to Gilead’s drug.
Despite the excitement, Dr Lawrence K. Altman, global fellow at The Wilson Center in Washington, was not ready to celebrate the preliminary findings.
The new data “offers a glimmer of hope” that remdesivir has an effect against COVID-19, but more scientific analysis is needed “comparing them to other studies of the drug that have shown mixed results”, he said in a statement.
Also on Wednesday, results were published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream.
Gilead said previously that those findings were inconclusive because the study was terminated early.
Originally published as Data on drug raises hopes in virus fight